Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 but no more than 12 patients are treated at the recommended phase II dose.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 12-84 patients (6-12 for stratum 1; 2-18 for stratum 2; 2-24 for stratum 3; and 2-30 for stratum 4) will be accrued for this study within 12 months.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective

Pathological confirmation of diagnosis not required in patients with liver mass, raised alpha-fetoprotein levels (at least 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma

Any solid tumor or lymphoma tumor type eligible

Must have had thoracic and upper abdominal CT scan, including entire liver and adrenals, within 28 days before study entry

Patients with glioma or brain metastases must be on a stable dose of corticosteroids and be seizure-free for the past month

No psychiatric illness or social situation that would preclude study compliance

HIV negative

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent immunotherapy for malignancy

Chemotherapy

More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

No other concurrent chemotherapy for malignancy

Endocrine therapy

See Disease Characteristics

No concurrent oral contraceptives

No concurrent hormone therapy for malignancy

Concurrent luteinizing hormone-releasing hormone agonists allowed

Radiotherapy

See Disease Characteristics

More than 4 weeks since prior radiotherapy and recovered

No concurrent radiotherapy for malignancy

Surgery

More than 2 weeks since prior major surgery

Other

Recovered from prior therapy

No concurrent medications that are known to be inhibitors of CYP3A4

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049400

Locations

United States, California

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010-3000

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States, 90089-9181

University of California Davis Cancer Center

Sacramento, California, United States, 95817

United States, Illinois

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States, 60153

United States, Kansas

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center